Vaniqa Information

The problem of unwanted facial hair extends beyond the normal need for bleaching, tweezing, hot waxing or the use of other depilatory applications. Many women with excess facial hair suffer from low self-confidence and/or feel less feminine secondary to the facial hair.

Vaniqa works by actively inhibiting an enzyme located in the root of the hair follicle, ornithine decarboxylase, which is necessary for cellular division and subsequently hair growth. Vaniqa does not interfere with the female hormones. The medication works actively on growing hair cells. These hair cells are in staggered growth patterns, therefore, Vaniqa may take 4-8 weeks to become fully effective. Women should continue to use their normal depilatory applications until Vaniqa becomes fully affective.

Women may continue to use their daily moisturizer, sunscreens, skin rejuvenation medications, cosmetics etc. in conjunction with Vaniqa. Individuals should wait approximately five minutes following the application of Vaniqa, and then apply their products in a normal fashion. (please consult your dermatologist prior to applying other prescription medications such as cortisone, etc.)

It is important to note that Vaniqa did not show to increase sensitivity to the sun in clinical studies. Potential side effects of Vaniqa include but are not limited to the following such as stinging, burning or itching sensations and redness (more likely if immediately applied after shaving), folliculitis and acne. These are unusual and affect less than 1% of all users.

Vaniqa is not recommended in children under the age of 12 or in pregnant or nursing women. If you are in your child-bearing years you should consult with your gynecologist/obstetrician prior to using the medication.

Individuals should apply Vaniqa twice a day to areas where excessive hair is prevalent. The use of Vaniqa should be limited to the area surrounding the lips and under the chin. Following application the treated area should not be washed for at least 4 hours. The medication should not be reapplied within an eight-hour period. Clinical studies have shown that unwanted facial hair will return to before treatment values approximately eight weeks following the discontinued use of the medication.

Individuals will realize that Vaniqa is working usually within the first eight weeks of treatment. Most women notice that they are using their depilatory applications agents less frequently during this time period. Clinical studies have shown significant results in more than 60% of those individuals treated. While Caucasian women have had a slightly better rate of response than African American women, Vaniqa has still been successful for all races involved in clinical studies. Studies were conducted with Caucasians and African Americans, Hispanics, Asians, and Native Americans.

Additional Information

This section contains more information concerning VANIQA that you should read prior to beginning treatment. This section does not list all the benefits and risks of VANIQA and does not take the place of discussions with your physician or healthcare professional about your condition or your treatment. If you have questions, talk with your healthcare professional.

What is VANlQA?

VANIQA (pronounced “VAN-i-ka”) is a prescription medication applied to the skin for the reduction of unwanted facial hair in women. The active ingredient in VANIQA is eflornithine hydrochloride. VANIQA also contains ceteareth-20, cetearyl alcohol, dimethicone, glyceryl stearate, methylparaben, mineral oil, PEG-100 stearate, phe-noxyethanol, propylparaben, stearyl alcohol and water.

How does VANIQA work?

VANIQA interferes with an enzyme found in the hair follicle of the skin needed for hair growth. This results in slower hair growth and improved appearance where VANIQA is applied.

VANIQA does not permanently remove hair or “cure” unwanted facial hair. It is not a depilatory. Your treatment program should include con-tinuation of any hair removal technique you are currently using. VANIQA will help you manage your condition and improve your appearance. Improvement in the condition occurs gradually. Don’t be discouraged if you see no immediate improvement. Be patient. Improvement may be seen as early as 4 to 8 weeks of treatment. Improvement may take longer in some individuals. If no improvement is seen after 6 months of use, discontinue use. Clinical studies show that in about 8 weeks after stopping treatment with VANIQA, the hair will return to the same condition as before beginning treatment.

Who should not use VANIQA?

You should not use VANIQA if you are allergic to any of the ingredients in the cream. All ingredients are listed on the tube and at the beginning of this leaflet. You should not use VANIQA if you are less than 12 years of age.

What should you tell your physician before using VANIQA?

If you are allergic to any of the ingredients, tell your physician. If you are pregnant or plan to become pregnant, discuss with your physician whether you should use VANIQA during pregnancy. No clinical studies have been performed in pregnant women. If you are breast-feeding, consult your physician before using VANIQA. It is not known if VANIQA is passed to infants through breast milk. If you are taking any prescription medicines, non-prescription medicines or using any facial or skin creams, check with your physician before use of VANIQA.

How should I use VANIQA?

Use VANIQA only for the condition for which it was prescribed by your physician. Do not give it to other people or allow other people to use it. You will need to continue your normal procedures for hair removal until desired results have been achieved. You may then be less bothered by the time spent in removing hair or the frequency of hair removal. VANIQA is to be used twice daily, at least eight hours apart, or asdirected by your physician. VANIQA is for external use only.

Follow the instructions for application of VANIQA carefully. Apply a thin layer of VANIQA to the affected areas of the face and adjacent involved areas under the chin and rub in thoroughly. You should not wash the treatment areas for at least 4 hours after application of VANIQA (eflornithine hydrochloride) Cream, 13.9%.

VANIQA may cause temporary redness, rash, burning, stinging or tingling, especially when the skin is damaged. If irritation continues, stop use of VANIQA and contact your physician. Avoid getting the medication in your eyes or inside your nose or mouth. If the product gets in your eyes, rinse thoroughly with water and contact your physician. If you forget or miss a dose of VANIQA do not try to “make it up”. Return to your normal application schedule as soon as you can.

You may use your normal cosmetics or sunscreen after applying

VANIQA, but you should wait a few minutes to allow the treatment to

be absorbed before applying them. If your condition gets worse with treatment, stop use of VANIQA and contact your physician.

What are the possible side effects of VANIQA?

VANIQA may cause temporary redness, stinging, burning, tingling or rash on areas of the skin where it is applied. Folliculitis (hair bumps) may also occur. If these persist, consult your physician.

How should VANIQA be stored?

VANIQA (eflornithine hydrochloride) Cream, 13.9%, should be stored at 15°C-30°C (59°F-86°F). Do not freeze. Keep this and all medicines out of the reach of children. This medicine was prescribed for your particular condition. Do not use it for another condition or give it to anyone else. This summary does not include everything there is to know about VANIQA.